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spk15: Good afternoon, ladies and gentlemen, and welcome to the IntelliGenX fourth quarter and full year 2021 financial results conference call. At this time, all participants have been placed in a listen-only mode. We will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Steve Kilmer. Sir, the floor is yours.
spk00: Thank you. Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dr. Horst Zerbe, IntelliGenX's CEO, Andre Godin, our President and CFO, Tommy Kenney, our General Counsel, and Dr. Dana Madsen, the company's Vice President of Business and Corporate Development. Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars, unless otherwise mentioned, and today's call may contain forward-looking information that represents our expectations as of today and accordingly are subject to change. We do not undertake any obligation to update any forward-looking statements, except as may be required by U.S. and Canadian securities laws. A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks and results may differ materially. Details on the risks and assumptions can be found in our filings with the U.S. and Canadian Securities Commissions. I would like now to turn the call over to Dr. Zerbe. Horst?
spk09: Thank you, Steve. Good afternoon, everyone. This is the fourth quarter and full year 2021 conference call. On today's call, I will provide a corporate update and discuss the progress we have made on our key pipeline projects. Then, André will review our Q4 and full year 2021 financial results. Following that, we will open up the line for your questions. First on our Atai partnership, in March of last year, we announced our strategic partnership with Atai Life Sciences, which has positioned us as a leading developer and manufacturer in the psychedelic therapeutic space, while also providing the financial capacity to continue progressing our pharmaceutical film product candidates towards commercialization. In connection with this partnership, Atai acquired approximately 25% of Intergenics for approximately $12.3 million. and granted us an initial secured loan in the amount of $2 million. Atai subsequently granted us a second secured loan in the amount of $500,000. In May, we entered into a second feasibility agreement with Atai for the development of novel formulations of salvinorin A, a naturally occurring psychedelic compound based on Intergenic's polymeric film technologies. In September, we entered into an amended and restated secured loan agreement with Attai, which committed $6 million in future financial support to Intergenix. This loan was required for us to meet certain requirements in conjunction with our uplisting to the TSX Big Board. Our stock began trading on Canada's most senior exchange on October the 7th. Our graduation to the TSX marks an important milestone for intergenics and should support the development of a stronger profile in the investment community. Last month, we received a third term loan from Atai in the amount of $3 million. We look forward to continuing to work with Atai to develop more efficacious treatments for patients with treatment-resistant depression and other mental health indications. Moving on to ResaPort, in September, we were pleased to announce that Exceltis, our ResaPort commercialization partner in 27 European Union countries, launched ResaPort in Spain. This was the first Versafilm-based product to launch in the global pharmaceutical market and was a major milestone for Intergenics. With the European migraine drug market expected to approach $1.5 billion by 2024, we are looking forward to working with Exceltis to launch Resupport in additional European countries in the future. Two words on Tadalafil. In September, we announced that Equestria Therapeutics, our co-development and commercialization partner for Tadalafil oral films, entered into a definitive license and supply agreement with an undisclosed leading men's health company. This is an important development in our collaboration with Equestiv that will help make Tadalafil oral films available to men suffering from erectile dysfunction and benign prostatic hyperplasia, or BPH. On cannabis films, in February of last year, the United States Patent and Trademark Office granted a notice of allowance for our U.S. patent application covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially tetrahydrocannabinol, or THC. This patent is intended to protect or disinfect products which enable THC absorption via the oral cavity thus minimizing the amount of THC that becomes subjected to unwanted oral first pass metabolism. In August, we transitioned from a development to commercial stage company by completing our initial shipment of CBD film strips in support of heritage cannabis launch of the CB4 control brand in Canada. We're looking forward to continuing to work with Heritage on all thin-film cannabis products. On Montelukast, in January, we were finally able to resume patient enrollment and dosing in our Phase II Buena clinical trial in patients with mild to moderate Alzheimer's disease. This proof of concept study is proceeding under the amended protocol with a higher daily dose that was previously cleared by Health Canada. We're looking forward to collecting valuable data on Monteluca's Versafilm safety, feasibility, tolerability, and efficacy for the treatment of mild to moderate Alzheimer's disease. In addition, we expect to explore the product's candidate's efficacy in a couple of other major indications. We hope to announce those details soon. Now a few words on animal health. In February of last year, Intergenics filed a new provisional patent application at the USPTO that covers the incorporation of high concentrations of active ingredients in products based on our beta-film proprietary veterinary oral film technology. This higher loading capability enables a formulation with the ratio of active to polymer of one to one So this new patent will allow us to incorporate high amounts of drug into our film while still keeping it small enough to administer easily to companion animals. Back in early 2020, we entered into a feasibility study agreement with an undisclosed partner for an undisclosed molecule for buccal absorption using intergenic proprietary Betafilm platforms. This feasibility study was successful, and in October of 2021, we entered into an additional R&D agreement with this undisclosed company to further optimize the buccal film and to manufacture films for a clinical study. And with that, I would now like to turn the call over to André for review of our financial results. André?
spk02: Thank you, Horst. Good afternoon, everyone. As Urs mentioned, I'd like to take a few minutes to discuss the company's financial performance for the fourth quarter as well as the full fiscal year ended December 31st, 2021. For the fourth quarter of 2021, the total revenue amounted to $494,000 compared to $790,000 in the same period last year. The change is mainly attributable to a $425,000 decrease in revenue from licensing agreement received in 2020. And that was partially upset by increases in R&D revenues of $94,000 and product revenues of $35,000. Operating costs and expenses were $3 million for the Q4 2021 versus $1.8 million for the corresponding three-month period of 2020. For Q4 2021, the company had an operating loss of $2.5 million compared to an operating loss of $1 million for the comparable period of 2020. Adjusted EBITDA was negative $2.3 million for Q4 2021 compared to $0.8 million for the same period last year. The net comprehensive loss was $2.9 million or $0.02 on a basic and diluted per share basis for Q4 2021 compared to net comprehensive loss of $1.3 million or $0.01 per share for the comparable period of 2020. Now let's look at the full year end of 2021. Total revenues for the year-end December 31st, 2021 amounted to $1.5 million, and this is consistent with the year-end ended December 31st, 2020. Operating costs and expenses were $9.5 million for the 12-month period ended December 31st, 2021 versus $7.8 million for the corresponding period of 2020. For the full year of 2021, the company had an operating loss of $8 million compared to an operating loss of $6.2 million for the comparable period of 2020. Our net comprehensive loss for the year was $9.9 million, or $0.07, for basic and diluted shares for the 12 months of 2021 compared to net comprehensive loss of $7.1 million, are also $0.07 per share for the comparable period of 2020. As at December 31st, 2021, the company's cash and short-term investments totaled $9.9 million, which did not include the $3 million secure loan granted to Intelligenix Corp by Atai in February of 2022. I would like to point out that A lot of the increase in the expenses is attributable to the fact that we received several Canadian government support programs related to COVID, covering, among other things, employee salary during 2020. On that, I will now turn the call back to Dr. Zerbe. Horst?
spk09: Thanks, André. In closing, I'd like to once again recognize our team for executing on our long-term strategy. And with that, I will now turn the call over for questions. I would like to remind you that our forward-looking statements apply to both our prepared remarks and the following Q&A. Thank you.
spk15: Thank you, ladies and gentlemen. The floor is open for questions. If you have any questions or comments, please indicate so by pressing star 1 on your touchtone phone. Pressing star 2 will remove you from the queue should your question be answered. And lastly, while posing your question, please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. Once again, that's star 1 if you have a question or a comment.
spk12: Please continue to hold while we poll. Okay, the first question is coming from Anthony Cantone with CRI.
spk15: Your line's live.
spk13: Hi, Dr. Zerbe and Andre. I wanted to ask about this Tilray arbitration. Can you give us a little information about the progress? Do you see this settling soon?
spk09: Hi, Anthony. It's Horst here. Thanks for the question. We sure can. I will turn over to Tommy Kenny, our general counsel, and he will comment on that. Hi, Anthony.
spk11: Thank you for your question. As you may know, the proceeding for the arbitration is confidential. What you can reiterate is that we're very confident that the added breach of the agreement by Tilray will be proven in arbitration. but right now we're continuing the proceeding as was announced to shareholder. We will be able to give you some more information when we have a closing of the proceeding when it's adjudicated or if there is a settlement in between, but for now there is not much we can say about the proceedings.
spk13: Okay, I have another question if I may.
spk09: Yeah, go ahead.
spk13: So Alzheimer's, I know that we restarted the high dosage Alzheimer's study. How long do you anticipate that it'll take to recruit? And when do you believe we'll get results of this Alzheimer's trial?
spk09: Yeah, okay, thanks for the question, Anthony. So I think I mentioned previously that enrollment has resumed after we had to put the study on hold due to the COVID situation. We expect the enrollment to be completed, let me see, in December of, I'm sorry, in August of this year. And then The last patient needs to be dosed for six months. That will take us to approximately February of 2023. Then comes the data crunching, so we expect final results from that study to be available by mid-2023, May, June. Okay.
spk13: Could you give us a little bit more information regarding your animal health care initiatives? I know that VetaFilm was exciting news that you had some good clinical results, and have we made any progress on moving forward with the commercialization?
spk09: We sure have. Dana can comment on that because Dana has been maintaining the contract with the partner there. Dana, can you please comment?
spk07: Of course. Hi, Anthony. So, as you're correct, we're moving forward on our one contract with a U.S. company on our VetaFilm platform. As you know, this is a prescription program, so we're manufacturing for another clinical trial some films, and after this, we will follow the regulatory proceedings. So this is not something that's going to be launched tomorrow. It will take some time. We need to do some additional trials. It's just a normal... regulatory pathway. But on the general animal health strategy right now, we did hire external help in end of Q4 last year. We presented our VetaSim platform to many animal health companies and three companies are at this moment actively evaluating our platform to see how it would fit within their pipeline and compounds to use our platform going forward. So stay tuned.
spk13: Okay, so this is still far in the distance as far as getting it on the market. So more than like two or three years?
spk07: Yes, that's correct.
spk13: And tell us about the psychedelics. We were excited about the Atai relationship, and I know that Atai has a couple of two or three compounds for psychedelics. Can you give us any progress on that?
spk09: Do you want to comment? Sure.
spk07: Yeah, of course I can. My pleasure. So for the psychedelics program, so one of them we're manufacturing right now, the GMP product for the clinical supply. There is the clinical program is going to be held overseas. So there has to be some permits being exchanged at this moment, but everything is on track to run the clinical trial. And on our end, our obligation is to submit those samples or the films for the clinical studies. So we're almost done with one project, at least for that stage. And for the other one, we're starting right now on the formulation optimization so that we also can manufacture then clinical trial samples for a clinical trial.
spk13: Okay.
spk07: And in addition, we're in discussion on other programs with our partner.
spk13: In the psychedelic space or some other space?
spk07: No in the psychedelic space.
spk13: Okay. Tell us about Tadalafil. Are we getting close to a product that's going to be commercialized?
spk09: So you broke off, Anthony. Can you please repeat?
spk13: Okay. So Tadalafil. Are we getting closer to commercialization of the thin film version of Tadalafil?
spk07: Yes, so I can answer that as well. So as you know, this is a partnered program with Equestiv, where both companies are responsible for preparing the answers for the CRL that the product has received. We're preparing right now some studies to answer the CRL. It's all underway. We're within the timeline that we also communicated to our commercial partner. And we're expecting that, you know, the product will be submitted to the FDA for review later this year. And then, you know, hopefully soon, early next year, we're going to see the product being approved and then launch preparation to happen.
spk13: Early in 2023. Okay.
spk07: Yes.
spk13: Okay. And tell me, so this is really for Andre.
spk02: I see that we have some debt maturing this year in 2022 are we how do we handle the maturities but I mean you know some of about 25 30 percent has already been converted of this debenture maturing in June and obviously we're hoping that some more can be converted but based on the share price right now the conversion is about 40 cents so if we don't get converted we have two option to reimburse it in cash or in chairs so the option at that moment would probably be to pay it in cash. But the decision hasn't been final yet.
spk12: Okay.
spk13: That's all I have. Okay.
spk09: Thank you very much.
spk15: Okay. The next question is coming from Jeremy Latin, private investor. Your line is live.
spk05: Yes, good afternoon. Thanks for taking my question. It's Latin, by the way. That's okay, though. Your previous person asked a couple of my questions, but one question I did have was, could you give us some information about how things are going with the migraine sales in Europe? Because we haven't heard anything, and a little bit of news, if it's good, would help.
spk09: That would, again, be Dana.
spk07: Yes, my pleasure. So our commercial partner Excitus in Spain sees a very good trend of the product. We had a sales meeting at the end of the year, and the product is certainly getting traction. They're launching a great campaign to really push the marketing and going out with a really nice promotion. At this moment, we're waiting for – I mean, it's still early days. They're launched in September. And the beginning, you usually wait for a little bit, but so far the traction is great. They really get a nice percentage of the market and it's all very hopeful. So that's as much as I can say.
spk05: Okay. So you can't provide any kind of numbers or what it added to your revenue or anything, like any detail? No.
spk07: No, it's too early. We're receiving royalties of the product. So royalties, you know, it will take a bit.
spk05: Okay. Any progress on moving into other countries? I mean, I know there are things going on in Europe right now, but have there been any discussions about expanding your market?
spk07: Yes, we are in fact scheduled to discuss the the global reach into other markets within Europe. So I do have a call set up with their global head of business development to really discuss the strategies and which markets they're going to go next. Certainly there's going to be a regulatory strategy behind because the product is approved in Spain and there are different ways to get it approved in the additional markets. But yes, that is certainly the goal.
spk05: Okay, very good. So there's progress there, in other words. Thank you. That's good news. The other question I had regarding CBD strips, again, we haven't heard anything since the summer, so six months ago, or more than six months ago now since you made your last shipment. Any more business happening there, or is that kind of quiet?
spk07: Of course. Do you want me to answer that question?
spk09: Yeah. Yeah, you should.
spk07: Okay. So for the cannabis franchise, we're really exploring now additional markets. As you know, Canada has a very unique regulatory framework that allows companies to market and launch cannabis films, which is not the same in, let's say, Europe. So we were working with regulatory experts to see how we can export into other markets and what it would take you know, to make our product fit into these categories, but there is a strong interest from, for example, Germany, where cannabis is allowed to import our products there, and we're working on this very actively. So there will be some progress coming.
spk05: So that's good. Thank you. That's good news as well. But nothing imminent here in Canada, or there's nothing sort of coming quickly. It's just you're working on it. Is that where you're at?
spk07: That's correct, yes.
spk05: Okay, very good. If I could just make a comment to everybody, and I don't know how you're going to react to this. There's been a lot of silence from management to the markets since, well, really over the last six months. We haven't heard much of anything from you. Would it be possible to keep silence? your shareholders and the markets up to date a little bit more effectively? Your investor relations person doesn't do anything. No offense if he's on the call. We don't hear anything. There's no news. And yours is a very news-driven stock. Let's not kid ourselves. Would it be possible to improve the flow of information? Because it sounds like you have a lot to say.
spk09: I mean, we have weekly... meetings to discuss shareholder communication we take that very seriously we don't want to get on a path that just in order to be heard we come out with with irrelevant or nonsense information like you know some companies apparently prefer to do that that is not really our style so We try to publish information that is really material and of value for investors to be heard. That's our general policy. So there are, at times, stretches where, while we are extremely active in our business development activities and here in the lab, that there is just not, that the information has not just advanced to the point that we can come out with meaningful information. So that's why we see at times stretches where we have to remain silent for the reasons that I, as I explained before, but that doesn't mean that things are not happening. Things are happening. We're just wait for the trigger moments and events. But we hear you loudly and clearly, and we will certainly make every effort to keep investors informed to the best of our abilities.
spk12: Okay, the next question is coming from, let's see here.
spk15: Tom Maglino, private investor, your line's live.
spk08: Yes, thank you for taking my call. My first question is regarding the migraine filing with the FDA. I believe it was supposed to be complete first quarter 2022. Where are you with this, and has there been problems while there's a delay?
spk09: We manufactured three full-scale batches as required by FDA to respond to the complete response letter. These three batches are currently in stability testing. We plan to contact FDA by mid-year to apply for meeting. to then discuss details of the of the response so You're right quite some time ago. We were under the impression that we could respond earlier this year unfortunately the Manufacturing of these of these batches Have stretched out a little more mostly because we are we were in conflicts in our manufacturing operation with Belbuca manufacturing, which was quite time consuming. So there has been, we have to admit that there has been a slight delay, but the batches have been manufactured. They look good. Stability testing so far gives us very promising results. So we are moving forward there.
spk08: So you're thinking submission would occur second half of this year and then take another six months? So we'd be looking at the earliest approval being January 2023?
spk09: I think January 2023 would be challenging. It would be 2023, but I think more towards mid-year. Dana, do you recall the more specific dates?
spk07: Yeah, so right now I think the plan is that we're going to have a six-month review, and that would bring us into early 2023, kind of mid to early 2023, somewhere there. Summer 2023, I think that's the most we can see at this moment. We still have to meet with the FDA. There are a couple of unknown items, which we don't know how they impact the timeline. And based on that, our current prediction is that we will have an approved product by the summer next year.
spk08: I'm sure we all agree it's about time that this thing gets moving. The cash flow was very disturbing last year. Do we see that minimizing? And from this call, it doesn't seem like there's much revenue going to be affecting this year on the horizon. Andre, can you give us some insight into how you see the cash burn increasing, decreasing, stabilizing, and what kind of revenue might we expect this year? Because I'm not hearing very much.
spk02: Yeah, I mean, we try to control our spending. Obviously, last year, we had a lot of support from the Canadian government, like I said, which obviously reduced our cash burn. But we're trying to stay very tight and minimize spending. But as we mentioned, we are looking to launch a couple of products next year. So we need to be commercial ready, which means we need to hire a few people in the back in the manufacturing because we might be, maybe not around the clock, but depending on the volume, we could be busy in the back. So apart from that, I don't see any substantial expenditure on our end because we, like I said, we keep everything very tight. In terms of revenue, we're hoping that, you know, for 2022, we'll have R&D revenue, obviously, and hopefully cannabis. And resupport, we haven't disclosed yet because we haven't received the report from our commercial partner in Spain. But we will be disclosing some royalty in the next quarter. And, you know, from that, you know, it should continue every, every quarter. I mean, the launch happened as mentioned, as Dan mentioned in September. So, you know, by year end, there's about 90 days before we get our royalty payments. So we will be in Q2 and then we'll get recurrent revenue coming from Resafort in Spain. But, you know, we're working very hard trying to obviously increase revenue and near-term revenue. And like I said earlier, 2023 hopefully will have an acoustic, you know, revenue increase.
spk15: Okay, the next question is coming from David Guyen, private investor. David, your line is live.
spk03: Well, good afternoon, everyone. Thank you for allowing me to speak here today. But I have two questions in regards to the BUENA trial. I know there was a recommencement. My specific question is that how many total patients are enrolled at the moment, and how many have been enrolled since the recommencements of this trial?
spk09: In total, I believe we're right now at around 35 or 36 in that neighborhood. And since we resumed enrollment, one patient has been, has commenced treatment, and two are now nearing the end of the evaluation and then should go on treatment. Not part of it. The plan is right now to give you a broader picture that with the sites that we have and the commitment that we will enroll one patient per month per site, that the full enrollment will have completed by August.
spk03: Okay, a follow-up to that is, what do the numbers need to treat to achieve any sort of clinical significance?
spk09: I'm sorry, I missed that acoustically. Can you please repeat?
spk03: What is the number needed to treat to achieve some sort of clinical significance?
spk09: I mean, the study has been populated so that based on the pre-trial stats that we were running, we can assume that we will have sufficient power to make a statement regarding efficacy. And just to classify, with the 70 patients, we believe the study has been sufficiently powered.
spk12: Thank you for that.
spk15: Okay, the next question is coming from Hugh Kiley, private investor. Hugh, your line is live.
spk14: Yes, good afternoon, everyone, and thank you for taking my call. Some of my questions have been answered, but I'd like to start with the Visipor. Are you allowed to say when the end date will be done on the facility, excuse me, stability testing? I know the batches were manufactured, but it may have been a hiccup, but any idea when the six months will end?
spk09: The six months will end around mid-year, let's say for the last batch. For the first batch, the six months will end around April. and then the second batch a little later, and the third batch around June, if I recall correctly, yeah.
spk14: Okay, that's a good time frame. And then, Mayor Dax, you start making inroads for the next meeting with the FDA?
spk09: Yes.
spk14: From the end of the stability, you reach out to see if you can have a sit-down session?
spk09: Yes, we're... Once we have sufficient data, that will be actually a couple months before we completed the six-months data for the third batch. We'll reach out to FDA to apply for a meeting to discuss filing strategy.
spk14: Okay. Thank you for that one. And the data on the irritation study is... End date of that, I know you said it was eight, it takes about eight months for that irritation study. Will that end by the end of June?
spk09: Dana, do you want to comment? You're in dialogue with the question.
spk07: Yeah, absolutely. So at this moment, the irritation study hasn't started because we had to make sure that we have the right people and that we're following the protocol that we discussed with the FDA. The plan is to start in April. There had to be new batches manufactured, so we had to be conscious about that and getting the time also at the CRO to have patients ready. So the current plan is to start the study in April.
spk14: So in April, eight months from now, we'll hopefully get an update. All right. And regarding... To that, I know you've entered an agreement with a U.S. commercialization partner. Any discussions going on for other countries worldwide?
spk07: Their capabilities are really for the U.S. market, and that's what we partnered with them for.
spk14: Is there any discussion with anyone else, any of the interested parties? Yes.
spk07: Of course, yes. Actually, in fact, Horst and I just came back from a partnering conference where I had numerous discussions about European rights for this product. So we're going to do our follow-ups and then see if those partners have the commercial capabilities to really support our program.
spk14: Okay. Thank you for that, Dana. And just, Dana, one of the questions, my connection was a little weak, but right now, We have agreements for, you know, with two animal health care companies, first one January 20 and another one this year, this past year. Is that accurate?
spk07: That is accurate, yes.
spk14: And did I hear, and correct me if I didn't hear it properly, you're in discussion with a host more of other veterinarian companies? Yes.
spk07: yes yes we are we send out our samples to evaluating it is a new technology so the concept is different than giving a tablet so a lot of companies have an interest in seeing how certainly the film would work in an animal setting they want to see it for themselves so they they're testing it and we will see what comes out of it and which programs would fit onto that platform but yes we are under the discussions of several companies
spk14: Okay. And last question is on the big heritage order that was talked about in the third quarter call, was that progressing order? Is that still in storage?
spk07: Everything has been shipped.
spk14: Everything has been shipped. All right. And I think that completes my questions. I'll go back in the queue.
spk09: Okay.
spk15: Thank you. Okay, the next question is coming from Adam Tuvero from psychedelicinvest.com. Your line is live.
spk01: Hey, how are you guys doing today? Thank you so much for taking my question. So the one I want to leave with was about heritage. So if all the heritage orders had shipped, shouldn't that have reflected more significantly on the books? The small order was about 75K in revenue, and you guys said that you shipped out a much larger order. Can you guys give any clarity on that?
spk12: Dana, can you comment?
spk07: I think it's more a financial statement problem. I think the orders were shipped I think when the invoices get paid, I would refer to Andre, but we shipped everything out, and there's certainly also royalties due, which a royalty report is in the progress right now. Again, Andre explained already that a lot of those contracts, there is a certain period after the quarter closes where the companies prepare the royalty reports and then pay. So this is all in the progress, but yes, you would see something reflected soon.
spk01: Okay, awesome. I appreciate that. Also, all right, so my next question is going to be specifically about the, all right, so did you guys, when I was listening earlier, did you mention SIBIN or was I hearing things?
spk09: No, we didn't. I didn't mention SIBIN in my introductory remarks. No.
spk01: Okay, let's talk about that. Okay, no problem. So that brings me to my next question. So you explained how that you were going to work on more psychedelic formulations, who I'm assuming is with a tie. So we know right now the two things you're working on, or we don't know, we're speculating is DMT and psilocybin related. Can you give us any insight on what other psychedelic medicines you might be working on? And it's going to be with a tie. Can you give a yes or no about that?
spk09: And we currently have two active programs. You mentioned the compounds. And we are in discussions for a third one. And I think commencement of that program is more or less imminent. And so with that, we would then have three programs in active development. What comes afterwards, We don't know yet. There will be more. I mean, we have a very long list of candidates from them, several dozen, which one will be next, we can't say. They haven't discussed that yet with us.
spk01: All right, awesome. And I appreciate you guys very much. In closing, I want to say also that If you guys or Dana or any one of you would ever want to do a Q&A, I would love to do one with you guys, and it would be an easy way for you guys to get some more exposure if that's what you want to do, because I heard a caller mention that earlier. I just want to throw that out there and say thank you very much, and I appreciate you guys.
spk15: Thank you. Okay, the next question is coming from Grant Gakey, private investor. Grant, your line is live.
spk06: Good afternoon, everyone. I think I heard earlier you said that part of the delay in manufacturing the Rizoport batches was because you were, I guess, manufacturing Belbuca. Is that accurate? That is correct, yeah. So would you expect any revenue from that or what?
spk09: We can't comment on that. I'm sorry. So I get strict instructions from legal that we are obligated to remain silent on the status of that program.
spk06: Okay. And then back to the heritage, I think the last caller mentioned on the revenues, and you all said that, I guess, the sales... reports or, you know, quarterly reports weren't in or whatever, but wouldn't you receive the manufacturing portion of that revenue soon after it's delivered?
spk12: Are we talking about CBD now?
spk02: Yes, heritage. Yeah, they've all been accounted for, so they've all been accounted for in our financial statements. So I think that we recorded some in Q4 and some in Q1 for a total of roughly about 100,000.
spk06: So even the large order has been accounted for in the 2021 financials?
spk02: I don't know what you mean by large order. But you all had a smaller order.
spk06: Y'all had a smaller order, and then you said you had a follow-up with a larger order that was in storage and has now been shipped. So are you saying that that's been accounted for?
spk02: Yeah, that's been accounted for, yeah.
spk06: Okay.
spk02: But we haven't received the royalties yet, but the manufacturing revenue has been accounted for.
spk06: Okay. And one last question. So back to what another caller was saying, it seems like there's probably – it doesn't appear that there's a lot of of revenue in line for 2022, except possibly, I guess, RIS report, which we don't know how much that is. Do you foresee you've got enough capital to get you through mid 2023 when some of the programs mature and start generating revenue?
spk02: Yes, this is what the intent is. we're basically okay for at least another 12 to 15 months, at which point we will be generating revenue. So we don't see the necessity of raising money unless it would be for specific opportunity. But for the burn rate, we're fine. Okay.
spk06: I guess from what I'm hearing, you know, Rizeport, Tattleville, to Lighterfield won't be, you know, even if they're approved mid-2023, I mean, we're really not going to start seeing much revenue until, you know, the latter part of 2023. Is that accurate?
spk02: Yes. We're expecting, like I said earlier, to launch two new projects and programs in 2023. And Tadalafil might be the third one, depending on the outcome of the irritation study and the timeline of the irritation study.
spk06: What are the, excuse me, what are the other two besides Tadalafil? Maybe I'm missing one. Resupport U.S. and DR1 we cannot disclose. Okay, so there's an undisclosed project that you feel is going to launch in early 2023.
spk02: It could potentially launch in 2023, yes. Okay. Thank you all. You're welcome.
spk15: Okay, the next question is coming from Joe Vilela, private investor. Joe, your line's live.
spk04: Hello and good afternoon. I have kind of a blast from the past item to ask about. It may, you know, it's related to that flow, so hopefully, I don't know, there's something there, but I doubt it. Back when you guys sold the 450XL royalty stream, as I understood it, there was a potentially significant milestone possibility, something like $23 million. or something like that of potential milestones of which Intelligenix would have the rights to 65%. It doesn't seem like that's happening or will happen. I'm just wondering if you can clarify for us whatever happened with those 450 milestones. Thank you.
spk02: Yeah, or if I can answer that. Yes, I mean, there was several milestones that were that were possible for us to receive after we monetize the asset. But unfortunately, you know, those milestones were based on achieving a certain level of sales, and those levels were not met. So unfortunately, even though we were entitled to receive them, if those levels of sales would have been met, it never did. So that's why we didn't get any of those milestones.
spk04: Okay. Is that something you're still tracking, or is it considered dead at this point?
spk02: No, it is dead because it was... per year and the levels of those sales needed to be met, let's say the year after we monetize and the following year. So there was two potential milestone that we could receive two years after we monetize the asset. But after that, there was no longer any milestone that we could receive. So it's gone.
spk04: Okay. Well, it seems that the timing of the monetization was, was, um, thank you very much. That was my only question. Thank you.
spk10: You're welcome.
spk15: Okay. The next question is coming from Hugh Kylie, private investor. Your line is live.
spk14: Yes. Again, I'll be short and sweet. Uh, Dana, a couple of quarters ago, uh,
spk07: inquired about the Vera Durham and you're in the potential discussion with interested partners any progress on that product yeah thank you for that question so you're absolutely correct we were in discussions it's a large company and that company had some reorganization the project was put on hold for a while and received recently a approve it, so we are moving forward with discussions. But at that point, we had to be on hold for quite a while because of some reorganizations at that company.
spk14: Okay, thank you. And then I guess this goes to Tommy. With the THC platform of products that you have, is that still... Are you prevented from discussing with other partners while this... to a... legal issue is being resolved?
spk11: It depends on the technology. Some technologies we cannot approach the partner because they were exclusively given to Tilray. Some other technologies are not partnered with Tilray and could be opened, but at this point we're trying to get clarity on the Tilray situation through arbitration and then make sure that we're clear to go and able to be in the market because it's a strategic opportunity for us to be in this field. So we hope that the arbitration will be shorter than the court proceedings. So normally arbitration could be quite expedient. So that's what we're hoping for. And we will make sure that this is dealt with as soon as possible. But in the meantime, we could still be discussing some opportunities with cannabis company, whether it's CBD or THC.
spk14: Okay. Thank you for that. And, uh, and the, just, uh, Do you expect a long drawn out trial with against bio delivery down in Delaware? I know it's scheduled for April. Do you expect that to be?
spk11: It is still scheduled for April. We're expected that the trial will go ahead as of today. You never know before trial. There could be a settlement, but right now we're expecting to attend trial late April.
spk14: OK. Okay, and that's all the questions I have. Thank you.
spk10: You're welcome.
spk15: Okay, the next question is coming from, let's see here, just one moment.
spk12: Raul Garcia in Dodge Holding. Oh. Just one moment. Okay, let's turn the floor back. to Dr. Zerbe for closing remarks.
spk10: Okay.
spk09: The line was a little distorted, but I understand we're done with the questions. So this would then conclude our Q4 and year-ended 2021 investor update call. And I would once again like to thank the entire Intergenics team for its hard work and dedication. our board of directors for their continued support of the management team, and finally, our investors for continuing to believe in and supporting us. Thank you and goodbye.
spk15: Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.
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